BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SpassageQ

    Reg #: 3027502366 · FEI: 3027502366 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPASS INC.
    Registration Number
    3027502366
    FEI Number
    3027502366
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 905, 396, World cup buk-ro, Mapo-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230386

    Owner / Operator

    Firm Name
    SPASS Inc.
    Operator Number
    10088247
    Address
    Unit 905, 396, World cup buk-ro, Mapo-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    03925
    Country
    KR

    US Agent

    Business Name
    Lighten Bridge LLC
    Contact Name
    Edward Park
    Address
    4408 Tortuga Lane
    City
    McKinney
    State
    TX
    ZIP
    75070
    Country
    US
    Email
    [email protected]
    Phone
    972 8000044

    Products

    Device Name Product Code
    Multivariate Vital Signs Index PLB

    Proprietary Names

    SpassageQ

    Establishment Types

    Manufacture Medical Device